A Chinese Registry to Evaluate the Association of Surgical Left Atrial Appendage Occlusion vs No Receipt of S-LAAO With Adverse Cardiovascular Events Among Petients Undergoing Coronary Artery Bypass Grafting.

Beijing Institute of Heart, Lung and Blood Vessel Diseases1 site in 1 country240 target enrollmentOctober 1, 2019

ConditionsHeart Surgery

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Heart Surgery
Sponsor: Beijing Institute of Heart, Lung and Blood Vessel Diseases
Enrollment: 240
Locations: 1
Primary Endpoint: All-cause death
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This is a prospective, single-center, randomized, active controlled, clinical trail to assess the efficacy and safety of surgical closure of left atrial appendage (LAA) in patients undergoing coronary artery bypass graft.

Registry

clinicaltrials.gov

Start Date

October 1, 2019

End Date

January 2023

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Beijing Institute of Heart, Lung and Blood Vessel Diseases

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subject undergoing coronary artery bypass grafting according to clinical indications;
•Age is more than 18 and less than 80 years old;
•Male and non pregnancy female;
•Subject understands study requirements and agrees to sign an informed consent from prior to study procedures.

Exclusion Criteria

•Pregnancy female;
•Participate in other clinical trial in the last 1 month.
•Subject doesn't agree to sign an informed consent from prior to study procedures.
•Subject undergoing repeat CABG, concomitant valve or other cardiac surgery.
•New York Heart Association (NYHA) Class IV heart failure.

Outcomes

Primary Outcomes

All-cause death

Time Frame: 3 year after discharge (These data is collected during follow-up visit at in-hospital)

Secondary Outcomes

Atrial fibrillation(3 year after discharge (These data is collected during follow-up visit at in-hospital))
Composite of ischemic stroke, thromboembolism and all death(3 year after discharge (These data is collected during follow-up visit at in-hospital))